MPS 3 ND Delivery Set w/AA w/106cm (16C)

GUDID 20634624530359

QUEST MEDICAL INC

Cardioplegia solution administration kit
Primary Device ID20634624530359
NIH Device Record Keya4c12f72-561e-4762-9abd-84859ccd7bdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPS 3 ND Delivery Set w/AA w/106cm (16C)
Version Model Number5ND3103
Company DUNS041810693
Company NameQUEST MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624530355 [Primary]
GS120634624530359 [Package]
Contains: 00634624530355
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTRHeat-Exchanger, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-15
Device Publish Date2021-02-05

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